Open-trial on the Prevention of Chronic Migraines With the CEFALY Device

This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Aurora,
Colorado80045

Purpose:

The purpose of this pilot study is to assess the efficacy of the Cefaly device in the
treatment of chronic migraine prior to implement a control trial where the size and final
protocol will be specified thanks to the outcomes of this pilot trial.

Criteria:

Inclusion Criteria:
- Patients with a history of chronic migraine meeting the diagnostic criteria listed in
ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated
migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic
migraine-recurrent painful ophthalmoplegic neuropathy, migrainous infarction) will be
enrolled. They are required during baseline to have ≥15 headache days with each day
consisting of ≥4 hours of continuous headache and with ≥50% of days being migraine or
probable migraine days; and ≥4 distinct headache episodes, each lasting ≥4 hours.
Both patients with or without acute medication overuse (medication overuse headache - MOH)
will be recruited
Exclusion Criteria:
1. Women: Pregnant, lactating or <6 months post partum
2. For patients already on treatment with medications in the following classes:
antihypertensives, antidepressants, antiepileptics, no dose change of those
medications is allowed for at least 3 months before start of baseline and during the
entire study period.
3. For patients treated with Botox, no injection within 4 months before start of
baseline or during the study.
4. Diagnosis of other primary or secondary headache disorders, except of Medication
Overuse Headache
5. A Beck Depression Inventory score of >24 at baseline
6. Psychiatric disorders that could have interfered with study participation
7. Intolerance to supraorbital neurostimulation that makes the treatment not applicable
(test of nociceptive threshold with specific Cefaly program)